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Stability of cidofovir in 0.9% sodium chloride injection and in 5% dextrose injection
L C Yuan1, G J Samuels, G C Visor
1Department of Formulation and Process Development, Gilead Sciences, Inc., Foster City, CA 94404, USA.
Insights
Cidofovir stability was confirmed in intravenous admixtures with 0.9% sodium chloride and 5% dextrose injections. The drug remained stable for 24 hours at both refrigerated and room temperatures in various IV containers and administration sets.
Area of Science:
- Pharmaceutical Sciences
- Drug Stability Studies
- Intravenous Infusions
Background:
- Cidofovir is an antiviral medication requiring careful preparation for intravenous (IV) administration.
- Understanding the stability of cidofovir in IV admixtures is crucial for safe and effective patient care.
- Previous data on cidofovir stability in common IV solutions and containers may be limited.
Purpose of the Study:
- To evaluate the stability of cidofovir in intravenous admixtures.
- To assess the impact of different concentrations, IV solutions, storage temperatures, and container types on cidofovir stability.
- To determine the physical compatibility of cidofovir with selected IV admixtures and administration materials.
Main Methods:
- Cidofovir admixtures at low (0.21-0.085 mg/mL) and high (8.12-3.51 mg/mL) concentrations were prepared in 0.9% sodium chloride or 5% dextrose injection.
- Admixtures were placed in polyvinyl chloride (PVC) or polyethylene-polypropylene containers and IV administration sets.
- Samples were stored for 24 hours at 2-8°C or 30°C, with cidofovir concentration analyzed by high-performance liquid chromatography at 0 and 24 hours. Physical compatibility was also assessed.
Main Results:
- Cidofovir stability was unaffected by storage at either 2-8°C or 30°C in 0.9% sodium chloride or 5% dextrose injection at both low and high concentrations.
- All admixtures remained clear, colorless, and free of visible particles or precipitation.
- No significant changes in pH or particle count (>10 microns) were observed, indicating good physical compatibility.
Conclusions:
- Cidofovir is stable in 0.9% sodium chloride and 5% dextrose injections for up to 24 hours when stored at refrigerated or room temperatures.
- The drug is compatible with PVC and polyethylene-polypropylene containers and IV administration sets.
- These findings support the safe preparation and administration of cidofovir IV admixtures within the studied parameters.
Abstract:
The stability of cidofovir in i.v. admixtures under refrigerator and room temperature conditions was studied. Admixtures of cidofovir 0.21 and 8.12 mg/mL in 0.9% sodium chloride injection or 5% dextrose injection and of 0.085 and 3.51 mg/mL in 5% dextrose and 0.45% sodium chloride injection were prepared in triplicate in polyvinyl chloride (PVC) or polyethylene-polypropylene containers and i.v. administration sets and stored for 24 hours at 2-8 or 30 degrees C. The lower concentration of cidofovir corresponded to an assumed dose of 0.5 mg/kg for a 40-kg patient, and the higher concentration to an assumed dose of 10 mg/kg for a 100-kg patient. Samples were removed at 0 and 24 hours and analyzed for cidofovir concentration by high-performance liquid chromatography. Physical compatibility was also studied. The stability of cidofovir in 0.9% sodium chloride injection and in 5% dextrose injection at low- and high-dose concentrations was unaffected by storage at either temperature. All admixtures were clear, colorless, and free of visible particles or precipitation. There were no substantial changes in pH or number of particles of > or = 10 microns in diameter. Cidofovir 0.21 and 0.12 mg/mL was stable in 0.9% sodium chloride injection and 5% dextrose injection in PVC and polyethylene-polypropylene containers and i.v. administration sets for up to 24 hours at 2-8 and 30 degrees C. Cidofovir was compatible with the injectable solutions studied.